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临床试验/NCT00129779
NCT00129779已完成不适用

A Randomised Control Trial Assessing the Effects of an Intermediate Care Package in Preventing Hospitalisation of Elderly Patients With Chronic Obstructive Pulmonary Disease (COPD)

Imperial College London1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2003年12月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
1
主要终点
Number of hospital admissions for exacerbations of COPD

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a term used for the conditions of chronic bronchitis and emphysema, diseases that are very common among the elderly and diseases that account for up to15% of all general medical admissions to National Health Service Hospitals. In a recent report on emergency admissions to acute hospitals in London, the King's Fund concluded that taking better care of elderly patients with COPD could reduce pressures on acute hospitals, and suggested that identification of vulnerable patients with lung disease and "pro-active," rather than "reactive," management might reduce the chances of hospitalisation. In this study, the investigators wish to compare a group of patients with COPD who are managed in the normal way, with another group of patients with COPD who receive all interventions known to be of some benefit to those with this condition. This will include a pulmonary rehabilitation programme, intensive education regarding self care, targeted advice to their general practitioners regarding how best to manage COPD, and regular contact with specialist respiratory nurses who will support the patients in their own homes by a combination of home visits and telephone contact. The value of such a comprehensive intervention will be studied, in terms of both its ability to reduce admissions to the hospital and its impact on quality of life.

详细描述

One hundred twenty-two patients over the age of 50 with COPD, admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of their condition will be recruited and randomised to routine and opportunistic care (n= 61) vs study care package (n=61) for 2 years. The patients randomised to the study package will take part in an initial pulmonary rehabilitation programme of 8 sessions of physical therapy and education (2 sessions a week for 4 weeks). Health related quality of life will be measured in the intervention and routine care groups using validated instruments (SF-36 and Canadian Respiratory Diseases Questionnaire). This will be followed by a baseline home visit and assessment from an experienced specialist respiratory nurse (Grade G), followed by monthly telephone calls and a home visit every 3 months. Each interview and visit will be a structured intervention addressing specific issues related to the management of COPD, with four possible specific outcomes including history taking; measurement of vital signs; discussion of treatment; appropriate vaccination and discussing and reinforcing self-management education. At the end of the 2 year study period the routine care and intervention groups will be compared for the following outcomes: number of admissions to hospital for exacerbations of COPD; number of unplanned visits to a general practitioner (with those initiated by study nurse identified separately); measures of quality of life (SF-36; CRDQ).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
盲法
None

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients over the age of 50 with COPD
  • •Admitted to Charing Cross Hospital in 2000-2004 with an acute exacerbation of COPD

排除标准

  • •Significant co-morbidity including severe heart disease and cancer
  • •Any condition that would preclude participation in the physical therapy component of a pulmonary rehabilitation programme, including musculoskeletal diseases

结局指标

主要结局

Number of hospital admissions for exacerbations of COPD

次要结局

  • Number of unplanned visits to a general practitioner
  • Measures of quality of life (SF-36; Canadian Respiratory Disease Questionnaire [CRDQ])

研究者

申办方类型
Other

研究点 (1)

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